The following data is part of a premarket notification filed by Innocoll Pharmaceuticals with the FDA for Collieva.
| Device ID | K081782 |
| 510k Number | K081782 |
| Device Name: | COLLIEVA |
| Classification | Dressing, Wound, Collagen |
| Applicant | INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
| Contact | Aaron Wyse |
| Correspondent | Aaron Wyse INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2008-09-30 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLLIEVA 77306733 3525403 Dead/Cancelled |
Bourne Capital Partners, LLC 2007-10-17 |